Application 075185
- Type
- ANDA
- Sponsor
- CARLSBAD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | TABLET, DELAYED RELEASE;ORAL | 75MG | No | No |
| 002 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | TABLET, DELAYED RELEASE;ORAL | 25MG | No | No |
| 003 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | TABLET, DELAYED RELEASE;ORAL | 50MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075185-001 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | |
| A075185-002 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | |
| A075185-003 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075185-001 | AB |
| A075185-002 | AB |
| A075185-003 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075185-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075185-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075185-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A075185-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075185-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075185-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A075185-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075185-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075185-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075185-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075185-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075185-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075185-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075185-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075185-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075185-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075185-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075185-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075185-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075185-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075185-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075185-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075185-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075185-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075185-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075185-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075185-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075185-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075185-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075185-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075185-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075185-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075185-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075185-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075185-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075185-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075185-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075185-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075185-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075185-001 | AB | 1 | 301d65b070ca… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Bryant Ranch Prepack | df5bb0e7-a3a9-4650-aae7-9a11ce615d5d | 2024-02-08 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Bryant Ranch Prepack | 7c3d8d33-8849-44df-bb57-57d32b96a0e4 | 2024-01-09 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 63629-2011 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Bryant Ranch Prepack | bced0ef0-085a-40db-9678-2bc6eb77d456 | 2024-01-09 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 63629-2012 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Bryant Ranch Prepack | e6a1ff58-a541-46f8-9663-eed53b7cf392 | 2023-11-16 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 63629-2013 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | A-S Medication Solutions | 9df87100-acf5-4b46-93b4-067b470136bd | 2023-10-23 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 50090-0543 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Proficient Rx LP | 73a46413-ecbc-4453-814d-bec955b375d2 | 2023-02-01 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 63187-222 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Proficient Rx LP | afce2de2-0c59-4191-bf79-782ca31e427d | 2022-07-01 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Proficient Rx LP | 947c0c1f-3573-4f69-ab82-8b50c43e5586 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0440-6396 | Diclofenac Sodium | Diclofenac Sodium | Liberty Pharmaceuticals, Inc. | ANDA | Current |
| 10544-188 | Diclofenac Sodium | Diclofenac Sodium | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-189 | Diclofenac Sodium | Diclofenac Sodium | Blenheim Pharmacal, Inc. | ANDA | Current |
| 42254-059 | Diclofenac Sodium | Diclofenac Sodium | Rebel Distributors Corp | ANDA | Current |
| 42291-230 | Diclofenac Sodium | Diclofenac Sodium | AvKARE, Inc. | ANDA | Current |
| 42291-230 | Diclofenac Sodium | Diclofenac Sodium | AvKARE | ANDA | Current |
| 42291-231 | Diclofenac Sodium | Diclofenac Sodium | AvKARE, Inc. | ANDA | Current |
| 42291-231 | Diclofenac Sodium | Diclofenac Sodium | AvKARE | ANDA | Current |
| 43063-693 | Diclofenac Sodium | Diclofenac Sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-694 | Diclofenac Sodium | Diclofenac Sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43353-784 | Diclofenac Sodium | Diclofenac Sodium | Aphena Pharma Solutions - Tennessee, Inc. | ANDA | Current |
| 45865-999 | Diclofenac Sodium | Diclofenac Sodium | medsource pharmaceuticals | ANDA | Current |
| 50090-0542 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-0542 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-0542 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-0542 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-0542 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-0543 | Diclofenac Sodium Delayed Release | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-0543 | Diclofenac Sodium Delayed Release | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-0545 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-0545 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-0545 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-0545 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-0545 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-0545 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50436-1003 | Diclofenac Sodium | Diclofenac Sodium | Unit Dose Services | ANDA | Current |
| 50436-1022 | Diclofenac Sodium | Diclofenac Sodium | Unit Dose Services | ANDA | Current |
| 51655-176 | Diclofenac Sodium | Diclofenac Sodium | NORTHWIND PHARMACEUTICALS | ANDA | Current |
| 53002-5360 | Diclofenac Sodium | Diclofenac Sodium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-5360 | Diclofenac Sodium | Diclofenac Sodium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-5370 | Diclofenac Sodium | Diclofenac Sodium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-5370 | Diclofenac Sodium | Diclofenac Sodium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55700-834 | Diclofenac Sodium | Diclofenac Sodium | Quality Care Products, LLC | ANDA | Current |
| 55700-834 | Diclofenac Sodium | Diclofenac Sodium | Quality Care Products, LLC | ANDA | Current |
| 55700-834 | Diclofenac Sodium | Diclofenac Sodium | Quality Care Products, LLC | ANDA | Current |
| 59088-093 | Inflammacin | diclofenac sodium, capsaicin | PureTek Corporation | ANDA | Current |
| 59088-093 | Inflammacin | diclofenac sodium, capsaicin | PureTek Corporation | ANDA | Current |
| 60760-153 | Diclofenac Sodium | Diclofenac Sodium | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-154 | Diclofenac Sodium | Diclofenac Sodium | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-154 | Diclofenac Sodium | Diclofenac Sodium | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61145-101 | Diclofenac Sodium | Diclofenac Sodium | RePharm Pharmaceuticals | ANDA | Current |
| 61145-101 | Diclofenac Sodium | Diclofenac Sodium | RePharm Pharmaceuticals | ANDA | Current |
| 61145-101 | Diclofenac Sodium | Diclofenac Sodium | REPHARM LLC | ANDA | Current |
| 61145-102 | Diclofenac Sodium | Diclofenac Sodium | RePharm Pharmaceuticals | ANDA | Current |
| 61145-102 | Diclofenac Sodium | Diclofenac Sodium | RePharm Pharmaceuticals | ANDA | Current |
| 61145-102 | Diclofenac Sodium | Diclofenac Sodium | REPHARM LLC | ANDA | Current |
| 61442-101 | Diclofenac Sodium | Diclofenac Sodium | Carlsbad Technology, Inc. | ANDA | Current |
| 61442-102 | Diclofenac Sodium | Diclofenac Sodium | Carlsbad Technology, Inc. | ANDA | Current |
| 61442-103 | Diclofenac Sodium | Diclofenac Sodium | Carlsbad Technology, Inc. | ANDA | Current |
| 61919-074 | Diclofenac Sodium D/R | Diclofenac Sodium D/R | Direct RX | ANDA | Current |
| 61919-074 | Diclofenac Sodium D/R | Diclofenac Sodium D/R | Direct RX | ANDA | Current |
| 61919-074 | Diclofenac Sodium D/R | Diclofenac Sodium D/R | Direct RX | ANDA | Current |
| 61919-075 | Diclofenac Sodium D/R | Diclofenac Sodium D/R | Direct RX | ANDA | Current |
| 61919-075 | Diclofenac Sodium D/R | Diclofenac Sodium D/R | Direct_Rx | ANDA | Current |
| 61919-075 | Diclofenac Sodium D/R | Diclofenac Sodium D/R | Direct_Rx | ANDA | Current |
| 61919-075 | Diclofenac Sodium D/R | Diclofenac Sodium D/R | Direct RX | ANDA | Current |
| 61919-075 | Diclofenac Sodium D/R | Diclofenac Sodium D/R | Direct RX | ANDA | Current |
| 63187-222 | Diclofenac Sodium | Diclofenac Sodium | Proficient Rx LP | ANDA | Current |
| 63187-222 | Diclofenac Sodium | Diclofenac Sodium | Proficient Rx LP | ANDA | Current |
| 63629-1011 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-1011 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-1011 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-1012 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-1012 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-1012 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-1534 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-2010 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-2010 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-2011 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-2011 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-2012 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-2012 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-2013 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-2013 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-2077 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-2077 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-7654 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-7654 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-7655 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-7655 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8555 | ORIG | 1998-11-13 |